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- 2025-12-25 13:58:17
- Policy
- Paclitaxel + Carboplatin + RT will be reimbursed
- by Lee, Hye-Kyung Jan 21, 2021 06:13am
- Paclitaxel+Carboplatin+RTprior chemotherapy, which required prior approval from the Director of the HIRA, will be reimbursed for anticancer therapy The HIRA announced that it plans to announce an amendment to the announcement of drugs prescribed/administered to cancer patients containing the above contents, and that opinion inquiry will be conducted by the 26th. In the case of resectable esophageal and marginal cancer, in order to receive Paclitaxel+Carboplatin+RT, a prior chemotherapy regimen, the medical institution had to submit an application for exceeding the scope of product approval to the HIRA. However, as a result of side effects evaluation for patients who used the same therapy as exceeding the scope of product approval, safety and clinical usefulness are recognized, so it is decided to recognize the same benefits as the alternative therapy Capecitabine + Cisplatin + CCRT. It was set to 5 cycles according to the clinical practice guidelines. The standards for reimbursement of anticancer drugs used for ovarian cancer have also been partially changed. for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation, or Genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy, Zejula, among monotherapy, changed the target of maintenance therapy and added therapy. Regarding maintenance therapy, there was a significant difference in progression-free survival in the clinical trial (NOVA) non-gBRCA patient group, but the NCCN guidelines prioritize the same therapy for BRCA mutant patients, and the sBRCA mutant group among non-gBRCA patients decided to recognize the benefit only for somatic BRCA patients, considering the clinical characteristics and effects similar to those of the gBRCA mutant group. It is recognized only for patients with BRCA mutation in consideration of the high demand for unmet medical care for new drugs that show sufficient effects in indications as a result of review of textbooks and guidelines regarding treatment regimens, and histological classification of patients subject to clinical trials. It was limited to highly serous ovarian cancer for reference.
- Policy
- Conditional approval on Celltrion COVID-19 treatment advised
- by Lee, Tak-Sun Jan 20, 2021 06:02am
- The South Korean health authority’s panel of experts verified the clinical results and advised an approval of Celltrion’s COVID-19 monoclonal antibody treatment candidate Rekirona with a condition to conduct Phase III trial. The panel recommended the drug to be used to alleviate the mild to moderate COVID-19 symptoms in adult patients. The Ministry of Food and Drug Safety (MFDS) stated a meeting for the advisory panel to verify the safety and efficacy in COVID-19 treatment and vaccine candidate was convened on Jan. 17 to discuss about the clinical results of Celltrion’s antibody treatment Rekirona. Prior to the consultation with the Central Pharmaceutical Affairs Deliberation Committee, the advisory panel was gathered to provide advice on clinical and non-clinical drugs and quality. The panel meeting consisted of eight external experts including infectious disease specialist, virologist, clinical statistic expert and other clinical trial experts, and four members from the Review Team and Clinical Trial Evaluation Team under MFDS COVID-19 Treatment Approval Evaluation Team. The advisory panel provided their assessment on the Rekirona injection’s clinical trial outcome to confirm the treatment’s efficacy and safety. The clinical efficacy was evaluated by how fast a patient recovers from seven COVID-19 symptoms (fever, coughing, shortness of breath, sore throat, muscle ache, fatigue and headache) after receiving the candidate treatment. The pharmaceutical mechanism was evaluated by timing how fast a patient’s viral test result change from positive to negative. Advisory panel “Shortened symptom alleviation time clinically meaningful" The trial participants either took the drug or a placebo twice-daily, when they expressed any one of the COVID-19 symptoms at a high or medium level. The researchers measured the time to alleviate or weaken all of their symptoms, after monitoring them until Day 14. As a result, the patients administered with the investigational drug took 5.34 days to recover from the COVID-19 symptoms, when the patients administered with a placebo took 8.77 days. The drug was confirmed to reduce the time to alleviate the COVID-19 symptoms by approximately 3.43 days. The panel judged the clinical outcome is meaningful as it statistically proved the drug could lessen the time to improve the COVID-19 symptoms. The trial also tested the participants who have received the treatment for the change in the viral load to verify the mechanism of preventing the viral infection in a human body by letting the drug to bind with the novel virus instead of a human body cell. The virus test confirmed there is no significant difference between the drug-administered group and the control group with the duration of time the test result change from positive to negative. Although the shortened duration was not statistically meaningful, the panel claimed the administration of the drug seemed to show a tendency to decrease the viral load. Recommends conditional approval, but needs sufficient Phase III evidence To confirm the safety of the drug, the researchers monitored the administered participants until Day 28 to observe adverse reaction and any internal infusion related reaction for its frequency, type and severity. In the end, the type of adverse reactions like hypertriglyceridemia and hypercalcemia were predictable as they were reported from Phase I trial already. The majority of the cases were mild or moderate, and the rate was similar to that of the control group. None of life-threatening case was reported. Overall, the advisory panel recommended approving Rekirona, with a condition to conduct a Phase III trial, but also they laid down a few advices on the product’s efficacy and effect; the treatment clinically demonstrated alleviating mild to moderate COVID-19 symptoms in adult patients aged 18 and over, who does not require supplementary oxygenation, but showed the symptoms within seven days of the injection. The advisory panel demanded the South Korean company to conduct a Phase III to verify meaningful decrease in the disease progression from mild-to-moderate to severe in sufficient number of patients, and to set a detailed guideline for the use in the clinical scene by discussing it with the government separately. Also, the panel advised the company to conduct another trial to verify the combination of the treatment candidate and other severe symptom treatment or an immunomodulator to be used on patients who needs supplementary oxygenation. MFDS plans to utilize the panel’s advices, recommended efficacy and effect and indication and outstanding evidence material to review the investigation drug, and to seek for advices on safety, efficacy and pre-approval consideration from the Central Pharmaceutical Affairs Deliberation Committee, a legal advisory panel under MFDS.
- Policy
- Yuhan's Lazertinib was approved
- by Lee, Tak-Sun Jan 20, 2021 06:02am
- The new drug Lazertinib developed by Yuhan for the treatment of non-small cell lung cancer has obtained approval from the MFDS. The technology was transferred to the global pharmaceutical company Janssen and is currently undergoing licensing procedures in other countries such as the United States. It is the first country in the world to obtain approval from the FDA. The MFDS announced on the 18th that it has approved Yuhan's non-small cell lung cancer treatment Leclaza (Lazertinib mesylate) as the 31st new drug developed in Korea. Leclaza is used in patients with advanced lung cancer with specific gene mutations who have previously been treated for lung cancer. It is a target anticancer drug that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth, and is less toxic to normal cells. The drug treats patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have previously been treated with EGFR-TKI. It selectively inhibits the epithelial cell growth factor receptor Tyrosine Kinase, which is involved in the growth, differentiation, and survival of cancer cells, and prevents cancer cell survival, proliferation and metastasis. Yuhan applied to conduct a phase III clinical trial after marketing based on the results of a phase II clinical trial conducted in Korea. The MFDS explained that the quality, safety and effectiveness, and post-marketing safety management plans were scientifically reviewed and evaluated according to the review criteria of the Pharmaceutical Affairs Law. The Central Pharmaceutical Affairs Review Committee, which includes experts treating lung cancer in the medical field, gave the final approval after consulting on the completion of the license and conformity to the system. The MFDS said that the approval of the new drug is expected to expand the range of drug options for the treatment of patients with recurrent non-small cell lung cancer. It emphasized that it will continue to provide scientific and thorough approvals and reviews, and by securing objectivity and transparency through expert advice, to ensure that the safety and effectiveness of treatments are sufficiently verified.
- Policy
- COVID-19 vaccination to start in February
- by Lee, Jeong-Hwan Jan 20, 2021 06:01am
- “COVID-19 vaccination begins at the end of February and early March, and will form herd immunity in November at the latest. If side effects occur only after the vaccination, the government will be fully responsible. I am urged to inoculate, and if the national anxiety increases and the need to take an initiative, as the president, I will not avoid it.” President Moon Jae-in said that COVID-19 vaccination will begin in late next month (February) and early March, and that he will form Herd immunity by November at the latest. He promised that the government will take all responsibility from mild to severe side effects that can occur after free vaccinations for all citizens, and said that he would be the first to get the vaccine as a president to alleviate public anxiety. On that day, BBC Bureau chief Laura Bicker asked President Moon, "If Korea had secured the vaccine a little faster, wouldn't the point of returning to daily life have been accelerated?" President Moon said that the domestic COVID-19 vaccine introduction and vaccination plan were systematically established. He especially hoped that he could succeed in forming herd immunity faster than any other country. The vaccination will be from late February to early March, and herd immunity is expected to be formed in November at the latest. President Moon said, "COVID-19 vaccine is the first vaccine developed in the world. We evenly purchased various vaccines to distribute the risks and secured sufficient quantities. Because vaccination takes time and the expiration date is short, herd immunity will be formed by starting the vaccination in February and the end of the vaccination management of the people by September." President Moon said, "If the vaccination is completed in the fourth quarter, the formation of Herd immunity is expected in November at the latest. It will be rather faster compared to other countries." He said, "The start of vaccination is at the end of February or early March, and there is a possibility that the quantity of COVAX facility will be introduced first, and the possibility that the time of introduction will be accelerated is being reported." The authorities will report it to the public in detail.“ President Moon said not to worry about the public being anxious about the side effects of COVID-19 vaccine. He said that if it helps relieve anxiety, he will be the first to receive vaccination as the president. The government will take full responsibility for any personal damage. President Moon said, "The quarantine authorities were very cautious in the process of signing a vaccine introduction contract, including side effects. As a vaccine that took more than 10 years was developed in one year with a fast track, we carefully observed the results of phase II/III clinical trials. "The MFDS approves global vaccines according to domestic standards. We analyze enough side effects. The public can trust the safety of vaccinations in Korea." President Moon said, "However, all vaccines have some side effects. From mild pain to more serious side effects. In this case, the government will take full responsibility for the side effects. So please do not worry about personal damage without government protection." He said, “Today (18th), the number of confirmed cases is about 300. It is clear that the third COVID-19 epidemic is over. If less than 400 people are confirmed during this week, the level of quarantine can be lowered. Because vaccination and treatment will be available soon, we will be able to succeed in quarantine ahead of any other country in the world and return to our daily routine after overcoming the crisis.”
- Policy
- NMO drugs ready for Korean market release within this year
- by Lee, Tak-Sun Jan 19, 2021 06:02am
- Roche’s NMO treatment Enspryng with satralizumab. A group of rare disease neuromyelitis optica (NMO) treatments are preparing for the South Korean market. NMO is a chronic disease with a no specific treatment. Recently, however, a number of treatments for the disease have passed the U.S. Food and Drug Administration (FDA) and they are now readying for the South Korean health authority’s approval as well. According to the pharmaceutical industry on Jan. 18, Mitsubishi Tanabe Pharma’s inebilizumab and Roche’s satralizumab have reportedly submitted application to the Ministry of Food and Drug Safety (MFDS) for the approval review. Inebilizumab received the U.S. FDA approval in last June. The U.S. health authority also granted an approval on satralizumab in last August as well. The first NMO treatment is Alexion’s Soliris. Initially, the drug was cleared by the FDA in 2007, indicated to treat patients with paroxysmal nocturnal hemoglobinuria (PNH). The additional indication to treat neuromyelitis optica spectrum disorder (NMOSD) was approved in June 2019, making it the first drug to treat the disease. Regardless of the title, the additional indication is not yet expanded in South Korea. The industry expects that Soliris would also follow through with the MFDS indication expansion procedure. NMO is an extremely rare disease, also characterized as an inflammatory demyelination that attacks the eye nerves and the spinal cord. The symptoms include numbness, weakening muscles and rapid loss of vision. Apparently, the disease is more likely to be expressed in Asian females, and the symptoms tend to stay permanently, while it could result in death due to shortness of breath. As all three drugs have applied for the approval, the patients may expect to get access to the first NMO treatment in South Korea. But the last hurdle is the pricing. Administering satralizumab costs over 200 million won per year. Soliris is famous in South Korea as ultra expensive drug. The financial impact on the National Health Insurance would be inevitable. The key to South Korean market release would be the successful pricing negotiation. The industry is closely following the relevant news to see who would become the first NMO treatment in the country and for how much with the reimbursement.
- Policy
- 68% to “wait and see” before COVID-19 vaccination
- by Jan 18, 2021 06:14am
- Sandra Lindsay, a nurse in the U.S., is taking the COVDI-19 vaccine (Source: CNN). Apparently, six out of 10 people in South Korea are intending to ‘get inoculated after confirming the outcome’ of the COVID-19 vaccine. Only 28.6 percent answered they would ‘get inoculated as soon as possible.’ As requested by a public survey research firm KSTAT Research, Professor You Myung Soon at Seoul National University Graduate School of Public Health surveyed 1,094 adults around the country from Jan. 8 through 10 for the 11th survey on their perception of COVID-19. The study found 67.7 percent would wait until later to see the performance of the vaccine to take the vaccine. Regarding the timing of initiating the inoculation in South Korea, 59.9 percent said they should wait and see, while 37.8 percent said as soon as possible. On the questionnaire asking about the fear and anticipation of the vaccine, 40.4 percent said they have a same level of both fear and anticipation, when 28.1 percent have more fear and 25.6 percent have more anticipation. 42. percent expects the timing of the vaccine commercialization would be around the middle of the year, and 35.4 percent and 11.2 percent answered late this year and next year, respectively. The majority of the survey participants, or 80.3 percent of them said they intend to receive free safety-proven vaccine (53.2 percent maybe, 27.1 percent absolutely). Professor You Myung Soon noted, “The survey provided an insight into the people’s sense of threat by the COVID-19 pandemic, prudence in vaccine development and use, and a positive level of trust in the healthcare system and the government’s vaccination plan. The government would need to endeavor to reflect the people’s intention and experience from various angle based on the understanding that their final judgment would be comprehensively made.” The survey participants answered the South Korean society in last 12 months of COVID-19 was not safe (59.7 percent), average (29.2 percent), and safe (11.2 percent). The ratio of the participants answering ‘not safe’ peaked from the entire series of the COVID-19 surveys Professor You has done so far. Regarding the third wave of the pandemic, 51.9 percent said the worst has yet to come, whereas 23.8 percent said the worst has passed. The participants also scored average 40 assessing if the daily life has recovered from the changes COVID-19 brought, when 100 indicates ‘completely.’ However, the score was lower in different demographics, such as the low income community (35.4), unemployed (35.5) and women in 30s (35.3).
- Policy
- Celltrion announced results of external clinical trials
- by Lee, Tak-Sun Jan 18, 2021 06:13am
- The MFDS will hold a verification advisory group meeting on the 17th to evaluate the appropriateness of the clinical trial results for COVID-19 treatment Rekirona developed by Celltrion. And it plans to announce the results on the 18th. After the verification advisory group meeting, the Central Pharmaceutical Affairs Review Committee and the final review committee decide whether to grant CMA through internal and external verification. The MFDS is currently operating the Central Pharmacy Review Committee on matters related to the safety and effectiveness of new drugs in accordance with the Pharmaceutical Affairs Law and is undergoing a procedure to seek advice. Taking into account the severe situation of COVID-19 pandemic, COVID-19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group and the Final Inspection Committee were additionally formed to go through a triple consultation process. The verification advisory group, the Central Pharmaceutical Affairs Review Committee, and the final review committee are in order. The Verification Advisory Group is a procedure in which the MFDS collects advisory opinions such as clinical, non-clinical, and quality from various experts prior to consulting the Central Pharmaceutical Affairs Review Committee. It was composed of about 30 experts in statistics, etc. Depending on the agenda, an advisory group meeting will be held in which experts in the field participated. The Central Pharmaceutical Affairs Review Committee is an advisory body of the MFDS pursuant to Article 18 of the Pharmaceutical Affairs Law. The advisory committee consists of about 15 members, including standing members of the Biological Drug Subcommittee and related experts, and consults on matters discussed by the verification advisory group and clinical usefulness. The Biologics Subcommittee is a specialized subcommittee for deliberation on the safety and effectiveness of biopharmaceuticals such as vaccines and genetically modified drugs. Prior to the final approval decision, the MFDS plans to hold a'final inspection committee' in which internal and external experts (about 10 people) jointly participate, and conduct a final inspection based on the results of the verification advisory group and the'Central Pharmaceutical Affairs Review Committee . The Ministry of Food and Drug Safety will hold a verification advisory group meeting on the clinical trial data of Celltrion's Rekirona on the 17th, and the results will be released on the 18th. At the verification advisory group meeting, it plans to receive advice on whether the clinical results for the indicators for measuring the clinical effectiveness and the indicators for measuring the principle of operation of the drug used in clinical trial of Rekirona are appropriate to acknowledge the therapeutic effect of this drug. The clinical efficacy measurement index is to evaluate how quickly the administered patient recovers from the seven symptoms of COVID-19 (fever, cough, difficulty breathing, sore throat, muscle pain, fatigue, and headache). A measure of how the drug works is to evaluate how short the time between positive to negative virus test results is reduced. An official from the MFDS said, "We will try to collect various opinions from experts in the process of reviewing the approval of the treatment and vaccine for COVID-19 so that a thorough approval and review can be accomplished.
- Policy
- Will COVID-19 vaccine by SK be released first?
- by Lee, Tak-Sun Jan 15, 2021 06:11am
- Among AstraZeneca's COVID-19 vaccines that have been applied for approval from the MFDS, it is highly likely that the vaccine that SK Bioscience is consigning and producing will be distributed for the first time in Korea. Recently, the MFDS has reported that item approval and lot release can be reviewed in duplicate to speed up the market. The industry analyzes that it will be possible to review vaccines previously produced by SK Bioscience for approval. The health authorities said through a briefing that they are in consultation with AstraZeneca to ensure that the vaccine that is distributed for the first time in Korea will be produced by SK Bioscience. On the 14th, an official from the MFDS said, "There is an exaggerated part of the press report that item approval and lot release are reviewed. Some overlapping periods can occur." Item approval and lot release are different. In the case of vaccines, after item approval, a lot release review is conducted for the products sold in Korea. Therefore, in order for item approval review and national lot release review to overlap, a commercial vaccine must be secured first. The MFDS is required to produce three commercially available lot numbers in advance and submit them as item approval review data according to the regulations on drug safety. Items produced for approval can be used for lot release screening. It is more likely to proceed with lot release for domestically manufactured vaccines rather than imported vaccines that take time due to customs procedures. The MFDS explained in a press release on the 11th that it plans to conduct an on-site survey on SK Bioscience for manufacturing and quality control evaluation during this month. This survey also includes production data for three lots numbers produced in advance. If the GMP (manufacturing and quality control standard) investigation is completed and the feasibility of the clinical trial is secured, it will be possible to review the lot release of commercial vaccines even before approval. The MFDS plans to shorten the period of item approval to a maximum of 40 days (currently more than 180 days) and lot release within a maximum of 20 days (currently 2 to 3 months). In order to start vaccination at the end of February, as announced by the government, lot release must also be carried out during the permit review period. AstraZeneca's COVID-19 vaccine was applied to the MFDS on the 4th. If item approval and lot release are up to 60 days, lot release should also be made during the approval review period. It is said that the health authorities are discussing it, but the vaccine that will be distributed for the first time in Korea is most likely a vaccine produced by SK Bioscience. When asked if the vaccine to be applied for the initial lot release screening is from SK Bioscience, the MFDS responded that it cannot be informed because the item is under review. The imported vaccine that AstraZeneca applied is known to be a product produced in Italy.
- Policy
- Tamiflu for oral suspension has withdrawn
- by Lee, Tak-Sun Jan 15, 2021 06:10am
- Tamiflu for oral suspension sold overseas In KoreaRoche's original influenza treatment Tamiflu for oral suspension is withdrawn from the domestic market due to the expiration of the product license. Generics for Tamiflu for oral suspension occupied in advance. As of the 13th, the MFDS withdrew Tamiflu for oral suspension 6mg/ml (Oseltamivir) from Roche Korea due to the expiration of the product license. It was approved on January 13, 2016. The main formulation of Tamiflu is capsule type, and patients such as children and the elderly have difficulty swallowing, so the drug in the capsules were ground into powder at a pharmacy and sold for pediatric use. However, since Tamiflu for oral suspension is mixed with water and taken in a liquid form, it is convenient to dispense at a pharmacy, and it is easy for children to take. Roche imported this suspension in Korea and obtained approval for the first time. However, due to the disagreement between Roche headquarters and Roche Korea, it delayed applying for Tamiflu for oral suspension and lost the competition with generic drugs. Hanmi received approval for Hanmi Flu Suspension one month later than Tamiflu for oral suspension, but it was first launched on the market in May 2016 after receiving insurance benefits. Since then, 30 kinds of generic drugs have been launched in 2017. Tamiflu for oral suspension was first approved in Korea, but it missed the timing of its release and started to withdraw from the market. Roche did not even apply for renewal and eventually decided to withdraw the license. Accordingly, Roche is expected to focus more on Tamiflu capsule. It is interpreted that the number of flu patients is decreasing due to the recent COVID-19 epidemic, which also affected the sales of Tamiflu for oral suspension.
- Policy
- Indications for Forxiga include CHF
- by Kim, Jung-Ju Jan 15, 2021 06:10am
- As the indication for AstraZeneca’s SGLT-2 inhibitor Forxiga 10mg (Dapagliflozin) has been extended to chronic heart failure, it is clearly covered in the benefit. On the 12th, the MOHW announced a partial amendment to the 'Pharmaceutical Reimbursement Listing Standard and Method', which establishes the reimbursement standards for additional authorizations for Dapagliflozin. Forxiga 10mg is an SGLT-2 inhibitor administered as an adjunct to diet and exercise therapy to improve blood sugar control in type 2 diabetes patients. The reimbursed price of Forxiga 10mg is ₩784. As of the 22nd of last month, the MFDS expanded the indication to chronic heart failure, requiring management of insurance benefits. Accordingly, the MOHW plans to include it in the notice to clarify the coverage of this indication. The benefits are recognized when Forxiga is administered to type 2 diabetes (general principle). If Forxiga is administered for an indication of chronic heart failure, the patient pays for the drug. The MOHW is planning to inquire industry opinions by the 14th, and it will be implemented and applied from the 15th if there is no specific matter.
